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HONG KONG DRUG LICENSING

If my pharmaceutical licence has previously been revoked, can I or my company apply again in future?

A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.

Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.

Drug Office, Department of Health Chinese Medicines Board

Q433 · Category I: Renewals, changes and penalties for non-compliance (Q401-Q450)
Technically, the law does not expressly prohibit an individual or company whose licence has been revoked from submitting a new application at some point in the future. In practice, however, this is extremely difficult. When you submit a new application, the regulatory authority will inevitably review your past record. You must provide highly persuasive evidence that the root causes of the licence revocation have been fully addressed, that you and your company have changed fundamentally, and that you are now a ‘fit and proper’ applicant. Rebuilding credibility takes a long time, and you will need to demonstrate a completely new and robust compliance management system.

📘 Regulatory basis

When assessing new applications, the regulatory authority closely scrutinises the applicant’s past record, including that of its directors and key management personnel, as part of its gatekeeping responsibilities.

📗 Drew Tang's recommendations

Rather than hoping to reapply after “turning over a new leaf”, make every effort to prevent your licence from being revoked in the first place. Compliance is an ongoing investment, not a cost that can be remedied after the event. Prevention is better than cure.

📕 Risk notice

The likelihood of success on reapplication is extremely low. The regulator will take a very cautious, even sceptical, approach. The effort required and the standards you must meet will be far higher than for a first-time applicant. Do not take the law lightly.

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